B9 - Global harmonisation of quality standards for medicines: Improving patient care and safety


Organised by the FIP SIG on Regulatory Sciences in collaboration with the FIP Industrial Pharmacy Section


Jennifer Dressman (Institute of Pharmaceutical Technology, Goethe University, Germany) and Igor Linhares de Castro (BIOCAD, Brazil)


Although coordination among regulatory authorities has increased in recent years through initiatives such as shared inspections of pharmaceutical manufacturing and the International Council on Harmonisation, there are still many instances in which drug products are regulated differently among countries, on both a regional and global basis. To meet the disparate requirements of the various regulatory authorities, similar but not identical laboratory work often has to be completed as well as preparing reports in different formats. The repetition of studies with slightly different protocols makes drug product approval time-consuming and inefficient, and ultimately the costs are passed along to the patient.

This session seeks to convey the need to resolve differences in regulation of drug products on both a regional and global basis, and describes current efforts to bring about harmonisation among different regulatory authorities. The benefits of harmonisation will be discussed from an industrial standpoint, explaining which redundancies occur and which savings would be gained by eliminating them. The mechanisms that have been put in place to achieve a central authorisation of drug product among a regional group of countries will be illustrated using South America as an example. On a global basis, a case study of the approach to harmonisation among the “Big Three” (USA, Europe and Japan) at the International Council on Harmonisation will be presented so that attendees can learn how this procedure works. Finally, an EFPIA representative will address which key issues should be prioritised for implementation of harmonisation in the coming years.


14:30 – 14:40 Introduction by the chairs

14:40 – 15:15

  1. Harmonisation on a regional basis to establish common requirements for drug approval
    Gustavo Santos (ANVISA, Brazil)
  2. 15:15 – 15:50 Benefits of harmonisation for industry, for regulators and for the patient — A success story of ICH
    Speaker TBA 

15:50 -16:10 Coffee/tea break

  1. 16:10 – 16:45 Highlights of the current ICH harmonisation projects and overview of what is on the horizon in the future
    Pär Tellner (EFPIA — ICH Steering Committee, Belgium)
  2. 16:45 – 17:20 Panel discussion, with a focus on future perspectives

Learning Objectives

At the end of this session, participants will be able to:

  1. Identify the benefits of harmonisation for regulatory, industry and the patient;
  2. Describe how harmonisation is achieved under the auspices of the International Council on Harmonisation;
  3. Describe how harmonisation is achieved on a regional basis;
  4. Identify important future areas for harmonisation of quality standard for medicines.

Type of session: Knowledge-based